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WO2006045054A2 - Dispositif de stimulation du corps neuromusculaire, peripherique et stimulation(s) electrique(s) dans la suberification d'une blessure par recuperation d'energie radioelectrique - Google Patents

Dispositif de stimulation du corps neuromusculaire, peripherique et stimulation(s) electrique(s) dans la suberification d'une blessure par recuperation d'energie radioelectrique Download PDF

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Publication number
WO2006045054A2
WO2006045054A2 PCT/US2005/037928 US2005037928W WO2006045054A2 WO 2006045054 A2 WO2006045054 A2 WO 2006045054A2 US 2005037928 W US2005037928 W US 2005037928W WO 2006045054 A2 WO2006045054 A2 WO 2006045054A2
Authority
WO
WIPO (PCT)
Prior art keywords
stimulation
chip
implantable
radio frequency
circuit
Prior art date
Application number
PCT/US2005/037928
Other languages
English (en)
Other versions
WO2006045054A3 (fr
Inventor
Constance M. John
Varghese John
Original Assignee
E-Soc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by E-Soc filed Critical E-Soc
Publication of WO2006045054A2 publication Critical patent/WO2006045054A2/fr
Publication of WO2006045054A3 publication Critical patent/WO2006045054A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation

Definitions

  • the present invention relates generally to systems and apparatus for providing electrical stimulation and more particularly to a device or a chain of devices for harvesting radio frequency (RF) energy that can be implanted in the human body to produce electrical stimulation in different regions of the body.
  • RF radio frequency
  • the device of the invention could be a chip or a nano or molecular system.
  • Synchronized neuromuscular stimulation encompasses conditions in which unilateral paralysis can be restored by using a RF signal to coordinate the contraction between a functional and paralytic muscle.
  • One application is facial nerve paralysis, often due to Bell's palsy. About 80,000 Americans a year are diagnosed with Bell's palsy and of those, 1O% to 15% are left with permanent visible defects such as ptosis of one side of the face.
  • RF harvesting has been published in the following article ("Communication between Functional and Denervated Muscles using Radio Frequency" authored by Doreen Jacob and Dr. Marlin Mickle in the Journal -Otolaryngology-Head and Neck Surgery, 2005)
  • VNS Vagus Nerve Stimulation
  • AD Alzhiemer's Disease
  • refractory epilepsy Conventional medication becomes refractory in certain patients these patients would be most benefited by such treatments.
  • VNS Vagus Nerve Stimulation
  • AD Alzheimer's disease
  • VNS Vagus Nerve Stimulation
  • the article, entitled “Cognition-Enhancing Effect of Vagus Nerve Stimulation in Patients with Alzheimer's disease: A Pilot Study” suggests that VNfS Therapy may improve cognition in patients with AD (Sjogren MJ, et. al., J. Clin. Psychiatry, (2002), 63, 972-980.)
  • GES Gastric electrical stimulation
  • the current device involves use of a pace maker with electrodes going to the stomach.
  • Transneuronix pioneered the technique and demonstrated that the technique has affects on obese patients.
  • the pacing was described as 24 hours a day, 180-400 ms pulse width, 40-100 Hz; 2 seconds ON, 3 seconds OFF with a burst amplitude of 3-8.5 rnA (Cigaina et.al, Obes Surg. 1999;9:333-334).
  • Fig. 1 which consists of a pace maker device that is implanted in the chest and with leads going to the Vagus nerve or to the stomach for gastric electrical stimulation (Lin Z, DigDis ScL, 50, 1328-1334, 2005).
  • Implantation of the conventional devices in the pheriphery is costly. As per Fig.l the implantation of the electrode 100 and the implantable pulse generator 120 is sometimes performed on different days. The incisions can be prone to infection in the immediate postoperative period. In some elderly patients with thin skin, the pulse generator 110 or wire can erode through the skin and become exposed to potential contamination. Infection or erosion often results in the need to remove the entire device, as antibiotic treatment alone in this setting rarely will clear the infection adequately. The lead 110 restricts the patient's mobility and may break. Furthermore, the battery 120 must be replaced every three to five years. Additional drawbacks of the pacemaker device include the risk of erosion of the leads or hardware, infection, and magnetic sensitivity.
  • this facilitates the remote station being encapsulated within a suitable protective material, such as a resinous plastic. Homopolymers, elastomers and silicon dioxide are also suggested as suitable materials for such purposes. Further, it is suggested that this facilitates miniaturization of the remote station and placing the remote station in functionally desirable locations which need not be readily accessible.
  • the remote station for example, could be implanted in a patient.
  • an electronic article containing a microchip having at least one antenna structured to communicate with an antenna remotely disposed with respect to the microchip is disclosed in U.S. Patent No. 6,615,074 entitled "Apparatus for Energizing a Remote Station and Related Method". Power enhancement is achieved using a voltage doubler.
  • the antenna of the disclosed apparatus is comparable in volume to a Smart Dust device.
  • Smart Dust is a combination MEMS/Electronic device on the order of 1 mm x lmm x lmm.
  • What is further needed is a device that can be designed as a chip. What is further needed is a device that is made of a chain of chips. What is further needed is a device that is a chip or a chain of chips that can be implanted anywhere in the body. What is also needed is a device that has a power source that does not need to be replaced.
  • the device such as the chip, also called BioMed-Chip , for electrical stimulation using RF energy harvesting of the present invention overcomes the disadvantages of the prior art, fulfills the needs in the prior art, and accomplishes its various purposes by providing a stimulation device that harvests radio frequency energy and is implantable in the human body.
  • the chip device of the invention may include an electrode on one side that can provide neuro stimulation and a harvesting side on the other.
  • the chip device instead of the electrode may have a pouch containing a drug, a protein or a plasmid for localized delivery.
  • the chip could have the ability to transmit information to other chips in the body or create an RF field for other chips in the vicinity.
  • a chip for stimulation using radio frequency harvesting includes a circuit, the circuit comprising a radio frequency harvesting power circuit and a stimulation circuit, and a plurality of small electrodes coupled to the circuit, the plurality of electrodes provide stimulation to targeted areas of the body.
  • the chip devices 230, 300, 420, 530, 610, 900 and 1010 are the same type of radio frequency harvesting chip.
  • the chip devices 220, 400, 410 and 620 are harvesting chips that can also generate an RF field. Li the drawings:
  • FIG. 1 is a schematic representation of a prior art device for vagus nerve stimulation, 120 is the pacemaker power supply, 110 is the leads, 100 are the electrodes;
  • FIG. 2 is a schematic representation of a chip stimulation device using RF energy harvesting in accordance with the invention, 200 is the chip antenna, 210 is the chip microcontroller and 220 is the chip electrode;
  • FIG. 3 is a schematic representation of the chip device and its use in the human body using RF energy harvesting in accordance with the invention, 300 is a single harvesting or RF generating chip, 310 is a chain of chips for stimulation, 320 is a ring of chips for stimulation;
  • FIG. 4 is a schematic representation of the use of a chain of chip device for gastric electrical stimulation
  • 400 is the RF harvesting/generating chip that is located subcutaneously
  • 410 is RF harvesting/generating chip stacked in between 400 and the chain of stimulating chips (420), 400 and 410 power 420 in accordance with the invention
  • FIG. 5 is a schematic representation of the chip device for localized drug delivery, 500 represents the drug chamber, 510 is the outside of the pouch containing the drug, 520 is the pore through which the drugs are eluted, 530 is the chip device;
  • FIG. 6 is a schematic representation of the chip stimulation device for vagus nerve stimulation in accordance with the invention
  • 600 is the vagus nerve
  • 610 is the ring of chips
  • 620 is the RF generating chips as described in Fig 4
  • FIG. 7 is a schematic representation of an external programming circuit in accordance with the invention
  • FIG. 8 is a schematic representation of an alternative embodiment of the external power circuit non-inductively coupled to the power circuit in accordance with the invention.
  • FIG. 9 is an illustration of a band aid layout with a chip electrode that can be used on wounds to provide enhanced healing in accordance with the invention.
  • FIG. 10 is an illustration of the use of the chip electrode device (1000) for muscle stimulation using a wrist watch transmitter to power trie chip in accordance with the invention.
  • the BioMed-chip consists of a flexible, implantable chip and antennae 200 having a dimension of approxiametly 9 mm 2 and a thickness of between 3 and 4 mm may be formed of a biocompatible material and include circuitry as further described herein. Electrodes 220 may include conventional electrodes or a flat electrode surface.
  • the chip has a microcontroller 210.
  • the circuitry may be operable to harvest and store RF energy, control the operation of the device and provide stimulation pulses and signals to the targeted areas of the body.
  • the chip can be used singly or as a chain or ring of chips.
  • BioMed-chips can also generate an RF field to power adjacent chips, or can transmit/ receive data from outside the body or to and from other chips inside the body.
  • an RF generation/transmitting circuitry 230 For such chips that can generate an RF field there is an RF generation/transmitting circuitry 230.
  • the BioMed-chip will include an antenna for harvesting or transmission, an electrode and a rechargeable storage device, either a thin film battery or capacitor that can be slowly charged over a period of time from the surrounding radio waves present in our environment.
  • FIG. 3 A device or "chip” for stimulation using RF energy harvesting of the invention is shown in FIG. 3.
  • the flexible, implantable chip 300 can be used as a single chip or as a chain 310 or as a ring 320. Use of a chain of chips inside the body would require stacking of a series of RF generating chips to be placed all the way to under the surface of the skin (subcutaneous).
  • 420 is put on the surface of the stomach and used to cause gasric electrical stimulation (GES).
  • the electrodes are attached to the surface of the stomach.
  • the surgery required for insertion of the chips on the stomach is fairly routine.
  • a second (410), third (400) or more RF generating BioMed chips would be put in a stacked fashion upto the surface of the skin (subcutaneous) in order to power the chips on the surface of the stomach.
  • the requirement for the RF- field generating chips would vary from patient to patient.
  • a pouch 510 on the back of the chip is used to store drug, proteins or plasmids. Stimulation of the pouch chamber 500 results in the release of the drug through the pore 520 or protein to the site at which the chip 530 is placed.
  • the chip is implanted to a localized site such as the knee for rheumatoid arthritis where delivery of a drug or therapeutic protein is of value to the specific site. Implantation of the drug chip is done under local anesthesia and is accomplished easily.
  • a ring of chips 610 are put on the the vagus nerve as shown in the figure.
  • the ring of chips would be clipped on and anchored to the surrounding tissue to prevent migration of the ring.
  • the use of one or more RF generating chips 620 more in a stacked fashion to under the skin surface (subcutaneous) is needed to power the ring of chips.
  • the procedure is performed under general anesthesia.
  • a neurosurgeon implants the ring of chips carefully attaching it to the vagus nerve.
  • Implantation of the RF-field generating BioMed chip is then done.
  • the number of chips needed would vary from patient to patient. Implantation is usually accomplished within 1 to 2 hours.
  • the chips are programmed to stimulate the vagus nerve at regular intervals (e.g., for 30 seconds every 5 minutes) at a frequency determined by the doctor and patient. The physician adjusts the frequency using a computer.
  • an example of a device for enhanced wound healing consists of a band aid with a Biomed chip 900 in the center.
  • the mild electrical stimulation is delivered through the electrode surface which is in contact with the wound.
  • FIGS.10 an example of a chip device for muscle stimulation with a Biomed chip 1010 the powering of the chip is done by an RF transmitter worn on a wrist watch 1000.
  • the chip circuitry may include a stimulation circuit as shown in FIG. 2 and a power circuit.
  • the chip also has a microcontroller for a chip may manage the internal stimulation circuitry.
  • a low frequency receiver may be coupled to the microcontroller and may convert RF communications into programming commands which the microcontroller interprets thus providing for ability to modify the chip functions.
  • the microcontroller may be operated with an internal clock frequency of 125 KHz, giving an efficient tradeoff between power conservation and proper functionality. This clock frequency allows pulse durations in increments of 32 micro-seconds. The output pulse duration can be adjusted between —60 and ⁇ 1 80 microseconds.
  • the programming input from the low frequency receiver chip 320 may be checked. If a programming signal is present, an input code may be read sequentially and the specified parameter adjusted to a new value, after which the program continues its pulsing routine.
  • An external programmer circuit 700 may include a microcontroller 710 including a PIC16LF87, an inductor/capacitor (LC) oscillating circuit 720 (125 KHz), and an intermediate MOSFET driver 730 including a TC4422 as shown in FIG. 7.
  • the MOSFET driver 730 may supply enough energy for driving the LC circuit 720.
  • a button (not shown) may be pressed, telling the microcontroller 710 to read its inputs and stimulate the MOSFET driver 730 to oscillate the LC circuit 720 according to a communication protocol.
  • Input voltages may be controlled by simple switches. Four switches may dictate the value to be sent, while five switches may dictate which parameter is to be changed.
  • a Phidget RFID antenna 740 designed for 125 KHz maybe attached to the high voltage side of a capacitor 750 of the LC circuit 720 for sending the programming signal.
  • the circuit 700 may be powered via a 12- Volt wall supply. The 12 V drives the MOSFET driver 730 and is regulated to 5 V for the switches and microcontroller 710.
  • An external powering circuit 800 may in one embodiment described above provide for near field harvesting and includes inductive coupling between coils 835 and 840.
  • the power circuit 865 for powering the stimulation circuit maybe non-inductively coupled to an external source of RF energy 880.
  • the power circuit 865 may be disposed in a wrist band worn by the patient, in a room transmitter or in a transmitter disposed in a building occupied by the patient.
  • the power circuit 865 may harvest ambient RF energy such as energy transmitted in space by using an inherently tuned antenna as described in U.S. Patent No. 6,856,291, the description of which is incorporated by reference in its entirety herein.
  • a rechargeable battery or other storage device may be employed to store harvested energy. "Non-inductive" as described herein being directed RF.

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  • Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention porte sur un dispositif de stimulation électrique par récupération de radiofréquence. Le dispositif appelé puce BioMed est implantable dans le corps d'un patient, le circuit de la puce comprenant un circuit électrique et de récupération de radiofréquence et un circuit de stimulation, ainsi qu'une pluralité d'électrodes couplées au circuit et qui assurent la stimulation sur des zones cibles du corps humain, et même profondément dans le corps.
PCT/US2005/037928 2004-10-18 2005-10-18 Dispositif de stimulation du corps neuromusculaire, peripherique et stimulation(s) electrique(s) dans la suberification d'une blessure par recuperation d'energie radioelectrique WO2006045054A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US61975704P 2004-10-18 2004-10-18
US60/619,757 2004-10-18

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Publication Number Publication Date
WO2006045054A2 true WO2006045054A2 (fr) 2006-04-27
WO2006045054A3 WO2006045054A3 (fr) 2007-02-22

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WO (1) WO2006045054A2 (fr)

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